The Effects on Auditory Function of RADiotherapy and Chemotherapy Treatments for Head and Neck Tumours (EARAD) (EARAD)

May 7, 2024 updated by: Professor Chris Plack, University of Manchester
Radiotherapy and combined radiotherapy and chemotherapy are used to treat most tumours in the head and neck region. Unfortunately, these treatments often result in hearing loss and tinnitus that has a negative impact on quality of life. This study will use a battery of sensitive tests, including measures of hair cell and neural function, before and after treatment, to measure the effects of these treatments on auditory function. The results will be compared with the individual radiotherapy dose characteristics, using state-of-the-art data mining technology, to identify the auditory substructures that are most sensitive to radiation with respect to the effects on auditory function. The data will provide the basis for new dose constraints to limit radiation doses to any identified substructures and to minimise loss in hearing ability for patients undergoing treatment for head and neck cancer.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The overall aim is to provide the data that will define radiotherapy dose constraints for individual substructures of the auditory pathway such that a better balance can be made between hearing loss and tumour control during radiotherapy for head and neck cancer. In particular the study aims to:

  1. Determine the impact of radiotherapy to the head and neck region on auditory function, including measures of hair cell and neural function
  2. Determine the interaction between radiation and cisplatin chemotherapy on auditory function
  3. Determine relations between different functional effects and radiation dose to substructures within the ear using advanced voxel-based data mining techniques
  4. Determine the auditory substructure that is most associated with speech-in-noise deficits
  5. Identify and validate a test which is most predictive of damage to that substructure, and could be the basis for future diagnosis
  6. Validate the importance of the localised sensitive substructure in an independent cohort

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with head and neck cancer and controls

Description

For Prospective Patient Cohorts:

Inclusion Criteria:

  • Diagnosed with head and neck cancer
  • An MDT treatment decision of radiotherapy +/- cisplatin based chemotherapy

Exclusion Criteria:

  • Hearing loss greater than 25 dB HL (average from 0.25 to 4 kHz) prior to the study
  • Existing hearing loss (self-reported- need for hearing aid)
  • An MDT treatment decision of carboplatin based chemotherapy
  • Involved in another research project where the treatment is known to be ototoxic
  • Unable to give informed consent

For Retrospective Patient Cohort:

Inclusion Criteria:

  • Previously diagnosed and treated for head and neck cancer
  • Radiotherapy treatment to one side of the head
  • Within 5 years post-treatment
  • An MDT treatment decision of radiotherapy +/- cisplatin based chemotherapy

Exclusion Criteria:

  • An MDT treatment decision of carboplatin based chemotherapy
  • Unable to give informed consent

For Retrospective Normal-Hearing Controls:

Exclusion Criteria:

  • Hearing loss greater than 20 dB HL (at any octave frequency from 0.25 to 4 kHz)
  • Unable to give informed consent

For Retrospective Hearing-Impaired Controls:

Inclusion Criteria:

  • Hearing loss greater than 20 dB HL (average from 0.25 to 4 kHz)

Exclusion Criteria:

  • Unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Discovery Phase - Radiotherapy only
25 patients undergoing radiotherapy only for head / neck cancer
Discovery Phase - Radiotherapy plus chemotherapy
25 patients undergoing radiotherapy plus chemotherapy for head / neck cancer
Validation Phase - Radiotherapy only
25 patients undergoing radiotherapy only for head / neck cancer
Validation Phase - Radiotherapy plus chemotherapy
25 patients undergoing radiotherapy plus chemotherapy for head / neck cancer
Retrospective Cohort
50 patients who previously received unilateral radiotherapy for head / neck cancer up to 5 years post-treatment
Normal Hearing Controls for Retrospective Cohort
50 controls with normal hearing, age- and sex-matched to retrospective cohort
Hearing Impaired Controls for Retrospective Cohort
50 controls with impaired hearing, age-, sex-, and audiogram-matched to retrospective cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Audiology test results for prospective cohort
Time Frame: T1 =baseline, before radiotherapy and T2= 3 months following radiotherapy.

For prospective patients undergoing radiotherapy to one side of the head, comparison of the test outcomes between the patient's two ears at baseline and 3 months, and relation to radiation dose characteristics.

For prospective patients undergoing radiotherapy to both sides of the head, comparison of the test outcomes for both ears at baseline and at 3 months, and relation to radiation dose characteristics.
T1 =baseline, before radiotherapy and T2= 3 months following radiotherapy.
Audiology test results for retrospective cohort
Time Frame: A single timepoint within 4 years post-treatment
Comparison of test outcomes between treatment and non-treatment ears and relation to radiation does characteristics. Further comparison with hearing impaired and normal hearing control groups.
A single timepoint within 4 years post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 9, 2019

First Submitted That Met QC Criteria

April 10, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHS001435

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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